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Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study.
- Source :
-
Resuscitation [Resuscitation] 2012 Apr; Vol. 83 (4), pp. 459-64. Date of Electronic Publication: 2011 Oct 12. - Publication Year :
- 2012
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Abstract
- Aim: Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the US.<br />Methods: PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data.<br />Results: Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1245 patients who received one or more blood transfusions within 6h of Emergency Department (ED) admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week.<br />Conclusion: PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials.<br /> (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)
- Subjects :
- Cardiopulmonary Resuscitation methods
Cohort Studies
Critical Illness mortality
Critical Illness therapy
Databases, Factual
Emergency Service, Hospital organization & administration
Female
Hospital Mortality trends
Humans
Injury Severity Score
Male
Organizational Innovation
Outcome Assessment, Health Care
Prospective Studies
Risk Assessment
Safety Management
Shock, Hemorrhagic diagnosis
Shock, Hemorrhagic mortality
Survival Analysis
Transfusion Reaction
Trauma Centers organization & administration
United States
Wounds and Injuries diagnosis
Wounds and Injuries mortality
Blood Transfusion methods
Emergency Medicine organization & administration
Registries
Shock, Hemorrhagic therapy
Wounds and Injuries therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1873-1570
- Volume :
- 83
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Resuscitation
- Publication Type :
- Academic Journal
- Accession number :
- 22001613
- Full Text :
- https://doi.org/10.1016/j.resuscitation.2011.09.019